ObesityNCT06169137
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
A study testing Early Time-Restricted Eating and Conventional dietary regimen (12-hr, 9:30a-9:30p) in people with Obesity and Body Weight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health. Objective: To learn how TRE affects women with different body sizes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Body Weight
- What is being tested?
- Early Time-Restricted Eating and Conventional dietary regimen (12-hr, 9:30a-9:30p)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH <ULN)
- BMI of 18-24.9 or >=30 kg/m^2
- In good general health as evidenced by medical history and/or screening laboratory evaluation.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis/treatment for immune/inflammatory disorder or other metabolic conditions that would interfere with study parameters, including diabetes, chronic kidney, chronic liver disease, history of hypoglycemia, and thyroid disease (with the exception of chronic controlled hypothyroidism as measured by TSH within normal limits)
- Current use of antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, or medications affecting sleep, circadian rhythms, or metabolism which affect parameters under investigation (examples include oral contraceptives, anti-diabetic agents, nicotinamide riboside, tryptophan, vitamin B3 supplements)
- Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily
- Factors that affect circadian rhythms including individuals who perform overnight shift work, report irregular sleep and/or eating schedules, and who regularly fast for more than 15 hours/day
- History of an eating disorder by self-report or medical history
Show all 14Show fewer
- Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet
- Inability to provide informed consent
- Pregnancy or lactation
- Unstable weight with more than 5% body weight change in last previous 3 months
- Engaged in competitive sports training and/ or unwilling to comply with exercise regimen in this protocol.
- Consumption of more than 3 servings of alcohol daily
- Current smoker or regular tobacco use, vaping, or other forms of nicotine within prior 3 months
- This study will recruit only women. The study design was informed by our Protocol NCT04728165 which investigates an identical 6:18h TRE intervention in males who are healthy and those with psoriasis. Based on our pilot data in men, the current study is needed to test our hypothesis in women. This study in women is a critical next step to replicate the findings in women and to understand sex-specific differences in TRE response and ketone metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health.
Read more
Objective:
To learn how TRE affects women with different body sizes.
Eligibility:
Healthy women aged 18 to 50 years.
Design:
Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic.
Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting.
Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay.
All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including:
- DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have.
- Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.
Read the detailed description
Study Description:
Intermittent fasting confers anti-inflammatory effects, although underlying metabolic mechanisms are poorly defined. This pilot study will explore ketone bodies as a mediator of inflammation in response to time restricted eating (TRE-6-hr feeding/18-hr fast) without caloric restriction compared to a more conventional dietary regimen (12-hr feeding/12-hr fast) in women classified as obese and lean.
Objectives:
Primary Aim 1: Quantify ketone body (beta-OHB) whole-body turnover after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
Primary Aim 2: Quantify CD4+ T cell responses after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
Secondary Aim 1: Determine metabolic response to short-term early 6-hr TRE in lean women vs women with obesity.
Secondary Aim 2: Determine immunomodulatory effects of short-term early 6-hr TRE in lean women vs women with obesity.
Exploratory Aim 1: Evaluate ketone body, hormonal, and cardiometabolic responses after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women classified as lean and with obesity.
Exploratory Aim 2: Evaluate effects of short-term early 6-hr TRE on perceived appetite, stress, and gastrointestinal symptoms.
Endpoints:
Primary:
- Change from admission day 0 in ketone body (beta-OHB) rate of appearance (Ra) after three days of 6-hr TRE
- Change from admission in CD4+ T cell responsiveness (Th17 polarization) after three days of 6-hr TRE
Secondary:
- Change from admission day 0 in post-absorptive glucose Ra quantified using [6,6-2H2]glucose (intravenous) after three days 6- hr TRE
- Change from admission day 0 in ketone body Ra in lean vs. obese women after three days 6-hr TRE
- CD4+ T cell responsiveness (Th17 polarization) in lean vs. obese women after three days 6-hr TRE
- Evaluation of ketone biology in isolated CD4+ T cells, using biochemical analysis and analysis of metabolic reprograming at the gene regulatory level
Exploratory:
- Circulating ketone body concentrations at admission day 0 and after 3 days of TRE
- Hormonal mediators of metabolic status (morning cortisol, fasting insulin and glucagon/incretins, thyroid hormones, sex hormone binding globulin, anti-mullerian hormone)
- Cardiometabolic biomarkers (glycemic, lipid, and inflammatory; trimethylamine N-oxide [TMAO])
- Perceived appetite, stress, and gastrointestinal symptom scores
- Conditions
- Obesity, Body Weight
- Being tested
- Early Time-Restricted Eating, Conventional dietary regimen (12-hr, 9:30a-9:30p)
- Keywords
- Diet, Time Restricted Eating, Inflammation, Ketone Bodies
- Medical subject headings
- Obesity, Body Weight, Intermittent Fasting, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted EatingBehavioural
Participants will be provided all meals to consume within a 6-hour timeframe (9:30-3:30p)
Conventional dietary regimen (12-hr, 9:30a-9:30p)Behavioural
Participants will be provided all meals to consume within a 12-hour timeframe (9:30a-9:30p)
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women (lean and obese) | Experimental | Ages 18-50 yearsBMI 18.0-24.5 mg/k^2 or BMI > 30 mg/k^2 Receives: Behavioral: Early Time-Restricted Eating; Behavioral: Conventional dietary regimen (12-hr, 9:30a-9:30p) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)
Within subject difference in ketone body (beta hydroxybutyrate) rate of appearance (Ra) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Measured: Day 0, Day 3
Change in CD4+ T cell responsiveness (Th17 polarization)
Within subject difference in CD4+ T cell response after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Measured: Day 0, Day 3
Secondary outcomes (4)
Change in post-absorptive glucose rate of appearance (Ra)
Within subjective difference in glucose Ra quantified using [6,6- 2H2]glucose (intravenous) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Measured: Day 0, Day 3
Change in ketone body rate of appearance (Ra) in lean women vs women with obesity
Between subject comparison in ketone body rate of appearance after 3 days of 6-hr TRE compared to a 12-hr eating window regimen in lean women vs women with obesity
Measured: Day 0, Day 3
Change in CD4+ T cell responsiveness (Th17 polarization) in lean women vs women with obesity
Between subject comparison in CD4+ T cell response after 3 days of 6-hr TRE compared to a 12-hr eating window regimen in lean women vs women with obesity
Measured: Day 0, Day 3
Ketone biology in isolated CD4+ T cells
Biochemical and metabolic reprogramming analysis at the gene regulatory level
Measured: Day 0, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start4 Sep 2024
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie T Chung, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169137
- Sponsor's protocol ID
- 10001746
- Other IDs
- 001746-DK
- Status last verified
- 7 Jul 2026
- First submitted
- 11 Dec 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide raw data (without identifying information) to journals or other researchers upon request.
Publications
Han K, Nguyen A, Traba J, Yao X, Kaler M, Huffstutler RD, Levine SJ, Sack MN. A Pilot Study To Investigate the Immune-Modulatory Effects of Fasting in Steroid-Naive Mild Asthmatics. J Immunol. 2018 Sep 1;201(5):1382-1388. doi: 10.4049/jimmunol.1800585. Epub 2018 Jul 18.
PubMed 30021766Puchalska P, Crawford PA. Metabolic and Signaling Roles of Ketone Bodies in Health and Disease. Annu Rev Nutr. 2021 Oct 11;41:49-77. doi: 10.1146/annurev-nutr-111120-111518.
PubMed 34633859Thota GP, Macheret NA, Glaros SB, Kacker IN, Cantor SL, Mabundo L, Malandrino N, Chen KY, Courville AB, Turner S, Yang S, Krenek A, Recupero TC, Klein RJ, Han K, Puchalska P, Crawford P, Sack MN, Chung ST. Effects of Time-Restricted Eating on Ketone Metabolism and Immunoregulation in Premenopausal Women: Protocol for a Pilot, Prospective, Single-Arm Dietary Intervention Study. JMIR Res Protoc. 2026 Mar 6;15:e81063. doi: 10.2196/81063.
PubMed 41791103
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
- ClinicalTrials.gov ID
- NCT06169137
- Acronym / sponsor ID
- 10001746
- Conditions
- Obesity, Body Weight
- Keywords
- Diet, Time Restricted Eating, Inflammation, Ketone Bodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health.
Objective:
To learn how TRE affects women with different body sizes.
Eligibility:
Healthy women aged 18 to 50 years.
Design:
Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic.
Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting.
Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay.
All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including:
- DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have.
- Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.
Detailed description
Study Description:
Intermittent fasting confers anti-inflammatory effects, although underlying metabolic mechanisms are poorly defined. This pilot study will explore ketone bodies as a mediator of inflammation in response to time restricted eating (TRE-6-hr feeding/18-hr fast) without caloric restriction compared to a more conventional dietary regimen (12-hr feeding/12-hr fast) in women classified as obese and lean.
Objectives:
Primary Aim 1: Quantify ketone body (beta-OHB) whole-body turnover after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
Primary Aim 2: Quantify CD4+ T cell responses after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women.
Secondary Aim 1: Determine metabolic response to short-term early 6-hr TRE in lean women vs women with obesity.
Secondary Aim 2: Determine immunomodulatory effects of short-term early 6-hr TRE in lean women vs women with obesity.
Exploratory Aim 1: Evaluate ketone body, hormonal, and cardiometabolic responses after short-term early 6-hr TRE compared to a conventional 12-hr dietary regimen in women classified as lean and with obesity.
Exploratory Aim 2: Evaluate effects of short-term early 6-hr TRE on perceived appetite, stress, and gastrointestinal symptoms.
Endpoints:
Primary:
- Change from admission day 0 in ketone body (beta-OHB) rate of appearance (Ra) after three days of 6-hr TRE
- Change from admission in CD4+ T cell responsiveness (Th17 polarization) after three days of 6-hr TRE
Secondary:
- Change from admission day 0 in post-absorptive glucose Ra quantified using [6,6-2H2]glucose (intravenous) after three days 6- hr TRE
- Change from admission day 0 in ketone body Ra in lean vs. obese women after three days 6-hr TRE
- CD4+ T cell responsiveness (Th17 polarization) in lean vs. obese women after three days 6-hr TRE
- Evaluation of ketone biology in isolated CD4+ T cells, using biochemical analysis and analysis of metabolic reprograming at the gene regulatory level
Exploratory:
- Circulating ketone body concentrations at admission day 0 and after 3 days of TRE
- Hormonal mediators of metabolic status (morning cortisol, fasting insulin and glucagon/incretins, thyroid hormones, sex hormone binding globulin, anti-mullerian hormone)
- Cardiometabolic biomarkers (glycemic, lipid, and inflammatory; trimethylamine N-oxide [TMAO])
- Perceived appetite, stress, and gastrointestinal symptom scores
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women (lean and obese) | Experimental | Behavioral: Early Time-Restricted Eating, Behavioral: Conventional dietary regimen (12-hr, 9:30a-9:30p)Ages 18-50 yearsBMI 18.0-24.5 mg/k^2 or BMI > 30 mg/k^2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH <ULN)
- BMI of 18-24.9 or >=30 kg/m^2
- In good general health as evidenced by medical history and/or screening laboratory evaluation.
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis/treatment for immune/inflammatory disorder or other metabolic conditions that would interfere with study parameters, including diabetes, chronic kidney, chronic liver disease, history of hypoglycemia, and thyroid disease (with the exception of chronic controlled hypothyroidism as measured by TSH within normal limits)
- Current use of antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, or medications affecting sleep, circadian rhythms, or metabolism which affect parameters under investigation (examples include oral contraceptives, anti-diabetic agents, nicotinamide riboside, tryptophan, vitamin B3 supplements)
- Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily
- Factors that affect circadian rhythms including individuals who perform overnight shift work, report irregular sleep and/or eating schedules, and who regularly fast for more than 15 hours/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time-Restricted EatingParticipants will be provided all meals to consume within a 6-hour timeframe (9:30-3:30p) | Behavioural | Premenopausal women (lean and obese) |
| Conventional dietary regimen (12-hr, 9:30a-9:30p)Participants will be provided all meals to consume within a 12-hour timeframe (9:30a-9:30p) | Behavioural | Premenopausal women (lean and obese) |
Primary outcome
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)
Time frame: Day 0, Day 3
Within subject difference in ketone body (beta hydroxybutyrate) rate of appearance (Ra) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Change in CD4+ T cell responsiveness (Th17 polarization)
Time frame: Day 0, Day 3
Within subject difference in CD4+ T cell response after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
4 secondary outcomes
Change in post-absorptive glucose rate of appearance (Ra)
Time frame: Day 0, Day 3
Change in ketone body rate of appearance (Ra) in lean women vs women with obesity
Time frame: Day 0, Day 3
Change in CD4+ T cell responsiveness (Th17 polarization) in lean women vs women with obesity
Time frame: Day 0, Day 3
Ketone biology in isolated CD4+ T cells
Time frame: Day 0, Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 30021766Han K, Nguyen A, Traba J, Yao X, Kaler M, Huffstutler RD, Levine SJ, Sack MN. A Pilot Study To Investigate the Immune-Modulatory Effects of Fasting in Steroid-Naive Mild Asthmatics. J Immunol. 2018 Sep 1;201(5):1382-1388. doi: 10.4049/jimmunol.1800585. Epub 2018 Jul 18.
- Background: PubMed 34633859Puchalska P, Crawford PA. Metabolic and Signaling Roles of Ketone Bodies in Health and Disease. Annu Rev Nutr. 2021 Oct 11;41:49-77. doi: 10.1146/annurev-nutr-111120-111518.
- Derived from this study: PubMed 41791103Thota GP, Macheret NA, Glaros SB, Kacker IN, Cantor SL, Mabundo L, Malandrino N, Chen KY, Courville AB, Turner S, Yang S, Krenek A, Recupero TC, Klein RJ, Han K, Puchalska P, Crawford P, Sack MN, Chung ST. Effects of Time-Restricted Eating on Ketone Metabolism and Immunoregulation in Premenopausal Women: Protocol for a Pilot, Prospective, Single-Arm Dietary Intervention Study. JMIR Res Protoc. 2026 Mar 6;15:e81063. doi: 10.2196/81063.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will provide raw data (without identifying information) to journals or other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie T Chung, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating and Conventional dietary regimen (12-hr, 9:30a-9:30p) in people with Obesity and Body Weight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra) (time frame: Day 0, Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169137, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.